EMA Marketing Authorization of New Drugs in June 2026

Shots: The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon. European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…

ByDipanshu DixitJuly 21, 2026

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …

ByRidhi RastogiJanuary 6, 2025

Insights+: The US FDA New Drug Approvals in May 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024 The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Amgen’s Imdelltra for the treatment…

ByDipanshu DixitJune 18, 2024

EMA Marketing Authorization of New Drugs in June 2026

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Insights+: The US FDA New Drug Approvals in May 2024

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